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Completed Not applicable Interventional Accepts healthy volunteers Results available

Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men

ClinicalTrials.gov ID: NCT02572401

Public ClinicalTrials.gov record NCT02572401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Reducing the Risk of HIV/STD Infection Among African American Men

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

African American men have by far the highest rates of HIV in the US, but there are few randomized controlled trials (RCTs) of interventions to dissuade heterosexually active African American men from engaging sexual risk behavior. This research seeks to address this gap in the behavioral intervention literature. That self-initiated behavior change, as well as intervention-induced behavior change, is often short-lived, eroding over time, is widely known; accordingly, this research also seeks to test a strategy to sustain intervention efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected intercourse with a woman will be randomized to the Steering Together in a New Direction (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a strategy to sustain intervention effects, the men also will be randomized to receive or not receive individually tailored text messages. The theoretical basis of the interventions is social cognitive theory and the reasoned action approach, which is an extension of the theory of planned behavior and the theory of reasoned action. Men will complete self-report measures via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12 months post-intervention. The trial will test whether the STAND HIV Risk Reduction Intervention as compared with the No-Intervention Control Condition, increases consistent condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The trial will also test whether STAND's efficacy is greater among men in the Text Messaging Intervention compared with men not receiving text messages. This will provide information on the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study will test for mediation of intervention effects: the hypothesis that STAND affects outcome expectancies and self-efficacy, which, in turn, affect consistent condom use.

Study identification

NCT ID
NCT02572401
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Pennsylvania
Other
Enrollment
391 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2011
Primary completion
May 31, 2013
Completion
May 31, 2015
Last update posted
Oct 14, 2019

2011 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pennsylvania Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02572401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 14, 2019 · Synced Sep 7, 2026

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